Good manufacturing practices (good manufacturing)

GMP is a series of measures, methods and technical requirements that run through the whole process of food production to ensure food safety. It is also an independent management system that pays attention to product quality, safety and hygiene in the manufacturing process. The application of good manufacturing practices in food, namely food GMP, mainly solves the quality problems and safety and hygiene problems in food production. It requires food production enterprises to have good production equipment, reasonable production technology, perfect sanitary quality and strict testing system to ensure the safety and quality of food meet the standards.

Section 1 Application of Good Food Production Practices

As early as World War I, the poor state of the American food industry and cheating in drug production prompted the United States

The Food, Drug and Cosmetic Law was born, and the quality of food and drug was guaranteed by law. Thus, the first national food and drug administration in the world-the US Food and Drug Administration (FDA) was established.

The United States is the first country to use GMP in food industry production, and the United States has done a good job in the implementation and enforcement of food GMP.

Lots of work. Good manufacturing practices (GMP) is a product quality assurance initiated by the United States.

Quantitative management methods. 1963 the us food and drug administration (FDA) formulates drug GMP, and 1964 implements it. 1969 the world health organization (who) requires member governments to formulate and implement GMP system to ensure the quality of drugs. In the same year, the United States promulgated the "current good practices of food manufacturing, processing, packaging and storage", which is called the Basic Law of FGMP (GMP). General principles of good food production technology (CGMP) formulated by FDA in 1969 is

All enterprises * * * abide by the same laws and regulations. American CGMP (modern food manufacturing, packaging and storage) 1 10, version 1996, including: definition, current good production practices, personnel, spacious factory building and ground, sanitary operation, maintenance of sanitary facilities and equipment, production process and control, warehouse and transportation, and food.

Since the implementation of GMP in the United States, many countries and regions in the world have adopted GMP quality management system, such as Japanese, Canadian, Singaporean, German, Australian, China and Taiwan Province Province. Actively implement the food GMP quality management system and establish relevant laws and regulations.

Influenced by the implementation of GMP for drugs and food in the United States, the Ministry of Health and Welfare, the Ministry of Agriculture, Forestry and Fisheries and the Japan Food Hygiene Association have successively formulated food manufacturing and circulation standards, hygiene standards and hygiene management essentials for various foods.

The Ministry of Agriculture, Forestry and Fisheries has formulated food manufacturing and circulation standards, including edible vegetable oil, canned food, tofu, pickles, sterilized packaged food, carbonated drinks, laver, tomato processing, hamburgers and beef patties, aquatic products, monosodium glutamate, raw noodles, bread, soy sauce, cold food, biscuits and macaroni.

The Ministry of Health and Welfare has formulated hygiene standards, including those for chicken processing, rice and ready-to-eat dishes, pickles, fresh west cakes, central kitchens and retail chains, and raw noodles.

The Food Hygiene Association has formulated the essentials of food hygiene management, including tofu, fried food, instant noodles, bread, sushi noodles, ordinary restaurants, senior restaurants and ethnic restaurants.

The above-mentioned "standards", "norms" and "essentials" are all instructive, and it is not illegal to fail to meet their requirements.

There are three situations in which GMP is implemented in Canada:

As a basic requirement that food enterprises must abide by, GMP has been written into legal provisions by government agencies. For example, the provisions on factory building in the Regulation on Meat Food Supervision formulated by the Canadian Ministry of Agriculture are mandatory GMP.

Government departments publish GMP guidelines to encourage food production enterprises to consciously abide by them.

Government departments can adopt GMP standards formulated by some international organizations, and food production enterprises can also adopt them independently.

Other countries use this guide as a guide to promote the implementation of GMP in their own countries. For example, the UK promotes GFMP (

Good food production practices

), Singapore is promoted by the Singapore Standards Association (SISIR), an NGO.

French, German, Swiss, Australian, Korean, New Zealand, Malaysian and other countries, as well as China's Taiwan Province Province, are also actively promoting the GMP of food.

The formulation of quality management standards for food enterprises in China began in the mid-1980s. Since 1988, 19 hygienic standard for food enterprises, referred to as "hygienic standard", has been promulgated. The purpose of formulating hygiene standards is mainly to specify the hygiene requirements of factories, equipment and facilities and the hygiene management of enterprises themselves in view of the backward hygiene conditions and management of most food enterprises in China at that time, so as to promote the improvement of hygiene conditions of food enterprises in China. The guiding ideology of these specifications is similar to the principle of GMP, focusing on all aspects of the whole production process before the finished product leaves the factory, not just the final product, and putting forward corresponding technical requirements and quality control measures for the whole food production process to ensure the final product is qualified. Since the publication of the above specifications, the overall production conditions and management level of China's food enterprises have been greatly improved, and the food industry has developed by leaps and bounds. In recent years, due to the rapid increase of some nutrition, health care and special food production enterprises, the variety of food is increasing day by day, and the measures of simply controlling sanitary quality are no longer suitable for the needs of enterprise quality management. In view of the fact that the time is ripe to formulate GMP for food enterprises in China, the Ministry of Health issued a document on 1998 (

GB 17405- 1998) and Good Manufacturing Practices for Expanded Food (GB 17404- 1998) are the first batch of food GMP standards promulgated in China, which indicates that the management of food enterprises in China has developed to a high level.

Main contents of good production practices in the second quarter

First, the principle of good production practices.

GMP is a specific requirement and a necessary good quality control measure to strictly monitor all links in the food production process, so as to form and improve the quality assurance system. GMP focuses on all aspects of the whole production process before the finished product leaves the factory, not just the final product. Its purpose is to ensure the quality of food from the whole process.

GMP system is an effective measure to control and restrain the long-term maintenance and behavior of production enterprises and managers, which embodies the following basic principles:

1. Food production enterprises must have sufficient qualifications, qualified technicians suitable for food production to undertake food production and quality management, and clarify their responsibilities;

2. Operators should be trained to operate correctly according to regulations;

3. Carry out production according to the standardized technological process;

4. Ensure that the production workshop, environment and production equipment meet the hygiene requirements and maintain good production conditions;

5. Materials, packaging containers and labels that meet the requirements;

6. Have suitable equipment conditions such as storage and transportation;

7. The whole production process is strict, with effective quality inspection and management;

8. Qualified quality inspectors, equipment and laboratories;

9. Verify the key steps of production and processing and the important changes in processing;

10. Production records should be made manually or by a recorder during production, to prove that all production steps are carried out according to the requirements of certain regulations and instructions, and the products meet the expected quantity and quality requirements, and any deviation should be recorded and checked;

1 1. Keep production records and sales records, so as to trace the whole history of each batch of products according to these records;

12. Minimize the risk of affecting the quality in product storage and sales;

13. Establish an effective recovery system for any batch of products through sales and supply channels;

14. Understand users' opinions on products on the market, investigate the causes of quality problems, and put forward treatment suggestions.

Second, the content of good production practices

GMP is divided into four parts according to FDA regulations: general rules; Buildings and facilities; Equipment; Production and processing control. GMP is applicable to all food enterprises, and it is a common-sense production hygiene requirement. GMP basically involves the maintenance of hardware facilities and personnel hygiene management related to food hygiene quality. Meeting the requirements of GMP is the first step to control food safety, which emphasizes that microorganisms, chemicals and physical contamination should be avoided in the process of food production, storage and transportation. China's food hygiene production standards are based on GMP and implemented according to mandatory national standards. This standard is applicable to enterprises or factories that produce and process food, and serves as the professional hygiene basis for formulating various food factories.

GMP is actually a quality assurance system including 4M management elements, that is, raw materials (materials) with specified requirements are selected, and qualified factory equipment (machines) are used by competent personnel (man) according to established methods.

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Quality assurance system to produce products with stable quality, safety and hygiene. The main purpose of its implementation includes three aspects: ① reducing human errors in the food manufacturing process; (two) to prevent food from being polluted or spoiled in the production process; ③ It is required to establish a perfect quality management system. The main points of GMP are: ① to confirm the safety of food production process; (2) Preventing food from being polluted by physical, chemical and biological hazards; (3) Double inspection system; ④ Establish and implement a complete management system for label management, production records and report filing.

Section III Health Food and Its Certification

First, the concept and classification of health food

Health food refers to food with specific health care functions. That is, it is suitable for specific people to eat, has the function of regulating the body, and does not aim at treating diseases. In addition to the requirements of general food, the most important thing is that health food must have functionality, which is the biggest difference between health food and general food. A health food should at least have certain functions of regulating human body functions, such as immune regulation, delaying aging, regulating blood lipid, regulating blood sugar, improving memory, promoting growth and development, resisting fatigue, losing weight, and inhibiting tumors. Those with unclear and uncertain functions cannot be used as health food. Because health food has obvious functions and is suitable for specific people, it generally needs to be eaten by special people specified in the product manual. If not all people eat it, it may lead to excessive nutrients and poisoning, or excessive contents of some nutrients in the body, resulting in poor balance of nutrients in the body, affecting human health and failing to achieve the edible effect of health food. As a kind of food, health food has its particularity, and its raw materials, efficacy, safety and product form are different from ordinary food. In addition to strictly evaluating the function, toxicity and stability of functional ingredients in health food, how to strengthen the supervision and management of health food enterprises and ensure that products can be produced according to the standards at the time of approval is a key factor related to whether the standardized management of health food can be truly realized.

Some scholars in our country divide health food into three categories according to the scope of application and service objects, which is more in line with the actual situation in our country. One kind is health food with the main purpose of improving health and physique, which can be eaten by general healthy people or sub-healthy people; The second is health food for people with special physiological needs or special jobs; The third kind of health food is mainly aimed at people with abnormal health, with the purpose of preventing and treating diseases. The specific classification is as follows:

(1) Nutrition and health food

1. Nutritional supplements (amino acids, vitamins, minerals)

2. Broad-spectrum health food

A. Immunoregulation

B. Anti-fatigue

C. beauty

(2) Special health food

1. Baby health food

2. Children's educational food

3. Special health food for pregnant women

4. Athletes' health food

5. Special types of health food (radiation resistance, hypoxia resistance, etc.). )

(3) Disease prevention and health food

Inhibitory effect of 1. on tumor

2. Regulating blood lipids

3. The role of preventing diseases and tumors

Regulate blood pressure

5. Improve osteoporosis, etc.

Two, the main contents of China health food good manufacturing practices.

According to the international good production practices and its certification system, according to the characteristics of health care products, it is the best way to solve the quality management problems of health food production, and it is a reliable guarantee system for the excellent quality, safety and hygiene of health food.

Good manufacturing practices for health food in China are consistent with international GMP in the purpose and principle. Therefore, this specification can also be called the health food GMP in China. Similar to the general framework of GMP, good manufacturing practices for health food mainly include the following contents:

(1) Basic requirements

The "Quality Management Standard for Health Food Production" has good practicability and operability. It is different from more than ten hygienic standards for food enterprises formulated by the state in the past. The latter mainly aims at preventing pollution, and mainly requires hygienic operation. The contents of Good Manufacturing Practice for Health Food include hygienic requirements and quality specification requirements in the production process of health food, including both quality control and pollution prevention.

Good manufacturing practices for health food mainly include seven parts: plant design and facilities, raw materials, production technology, quality management, storage and transportation of finished products, personnel and hygiene management. The basic requirements of quality control are:

1. All production and processing must be clearly defined, and systematic inspection must be carried out according to product and process characteristics, and it is proved that production can be carried out according to product quality requirements, process requirements and specifications;

2. Verify the key links and possible influencing factors of production and processing, and formulate necessary control measures in advance;

3. Provide all necessary facilities, including:

(1) qualified and trained personnel;

(2) Suitable workshop and space;

(3) Applicable equipment and facilities;

(4) Correct materials, containers and labels;

(five) the audited rules, regulations and records;

(6) Suitable storage and transportation conditions and equipment;

4. Correct production instructions and quality control;

5. Production operation, storage and transportation processes that meet the requirements of the specification;

6. Quantity and quality control of raw materials, intermediate products and final products

7. Save samples and production records.

(2) personnel

1. principle. There are enough qualified personnel who can undertake the task of ensuring the production of health food that meets the standard requirements. According to the different roles played by different personnel, different requirements are set for technical directors, production and quality management departments, full-time technicians, quality inspectors and general employees of enterprises.

2. Key requirements. Considering that the production and operation of health food have higher technical and quality requirements than general food production, the specification puts forward different qualification requirements for technical leaders, quality management departments, technicians and production personnel of health food enterprises. It should be noted that because these personnel have different roles and responsibilities in the quality control system, they should not replace each other, and personnel with different responsibilities should undertake their own production or quality management responsibilities according to the corresponding authorization.

On-the-job training and correct implementation are the basis for the implementation of standards. The Code specifically stipulates that employees must receive food laws and regulations education and corresponding technical training before taking up their posts. Enterprises should establish training assessment files, and the person in charge of the enterprise and the person in charge of the production and quality management departments should also accept the professional training of health food from the food supervision departments at or above the provincial level and obtain the certificate of conformity. (3) Design and facilities

1. principle. The principle of design and facilities stipulated in Good Manufacturing Practice for Health Food is that the design, space, structure and maintenance of the plant and equipment are conducive to the implementation of control according to the quality control requirements required by the specification. The workshop should avoid the adverse effects of external and cross-contamination factors on products, so as to minimize the risk of errors.

2. Key requirements. The production conditions of health food must meet the requirements of the national General Hygienic Standard for Food Factories. Here,

On this basis, according to the conditions of health food production, the hardware facilities required for producing different health foods are specified. This part focuses on the clean workshop and its corresponding auxiliary facilities. The grade requirements of clean workshop refer to the general clean requirements of drug standards of china and the world. At the same time, according to whether there is terminal disinfection, different cleanliness requirements are put forward.

(4) Requirements for raw materials

1. principle. Whether the content and function of functional ingredients in health food meet the requirements depends largely on the quality and control of raw materials. Raw materials must meet the required specifications and standards; All raw materials must be inspected according to the specified contents.

2. Key requirements. This part focuses on the management system of identification, acceptance, distribution and use of raw materials in procurement, storage and feeding, and strictly controls the source, origin, quality specifications and hygiene requirements of raw materials. It is required that all the treatment processes of raw materials from purchase to use must be carried out by the responsible person in accordance with the regulations, so as to maintain its original quality and avoid pollution. Every working procedure should be recorded. If the purchased intermediate products and products to be packaged are used as raw materials, they shall be managed as raw materials when purchasing.

(5) production process.

1. principle. Production operations should be carried out in strict accordance with the prescribed procedures to avoid blindness and randomness. Each working procedure has special post regulations. According to the requirements of product quantity and quality specification, the working procedure can only be passed after acceptance, so as to ensure the predetermined requirements.

2. Key requirements. The production process includes the collection and feeding of raw and auxiliary materials, batching and processing, cleaning, sterilization and cleaning of packaging containers, product sterilization, filling or filling, packaging and labeling. The requirements of good manufacturing practice on the production process of health food include the formulation of standard operating procedures, the rational allocation of production personnel, equipment and materials, the prevention of cross-contamination, the filling and filling environment, and the packaging conditions of finished products. In addition, in view of the backward production technology of some health foods, it is impossible to realize mechanized production, so the quality and hygiene requirements of each batch of production can not be guaranteed, and it is clearly stipulated that mechanized operation should be adopted in key control links. In order to ensure the correct implementation of the specification, it is also stipulated to formulate quantitative operation standards and record inspection systems for key control links of quality, health and safety.

(6) Storage and transportation of finished products

1. principle. Store and transport according to the specified conditions to ensure that the storage time and temperature will not adversely affect the products. Records reflecting product batches, sales targets and quantities shall be kept for verification.

2. Key requirements. The quality and hygiene guarantee measures of health food before and after leaving the factory are stipulated.

(7) Quality management

1. principle. Formulate and check the sampling, specifications, standards, inspections and regulations of relevant institutions. Determine whether the standards of implementation procedures in each link are consistent. Quality management and production process are equally important to ensure the full implementation of GMP. Quality management institutions and production institutions cooperate with each other, supervise each other, and form

The whole content of GMP. Quality management is the core of GMP.

2. Key requirements. The content of quality management includes: establishing an independent quality management organization suitable for production capacity and formulating a quality management system, which must correspond to all contents of the production process. Compared with the implementation of the production specifications of general food factories, the General Technical Specifications for Health Food Production puts forward higher requirements for the quality management of food enterprises, clarifies the rights and responsibilities of the quality management department, and also makes specific provisions on the equipment conditions, personnel conditions and inspection requirements required for quality inspection.

(8) Health management.

1. principle. The general hygiene management of a factory can be equated with a well-managed food enterprise, meeting the requirements of the General Hygienic Standard for Food Factories.

2. Key requirements. The contents include pest control, pest control, toxic and harmful treatment, animal feeding, sewage treatment and by-product treatment. The General Hygienic Standard for Food Factories has made detailed provisions on the sanitary facilities and management of food factories, and the hygienic management content required by this standard shall be implemented according to the General Hygienic Standard for Food Factories.

Section 4 Market Access and GMP Certification of Food QS Health Food

First, the general procedure of food certification

Good food production practice is an independent quality assurance system, aiming at improving consumers' good food practice.

Fan's cognition and trust, some countries and regions have carried out voluntary certification of good food norms. Taiwan Province Province, China since

GMP certification started from 1989. At present, there are nearly 30 kinds of GMP-certified foods, such as beverages, cold drinks, flour, candy, tea, noodles, edible oil, canned food, aquatic products and meat products.

Food GMP certification procedures include application acceptance, data review, on-site inspection and evaluation, product sampling, certification publicity, certificate issuance, follow-up evaluation and other steps.

Food enterprises should submit applications. The contents of the application include product category, name, component specification, packaging form, quality and performance, and copies of company registration, factory layout, mechanical equipment layout, technical personnel education certificate and training certificate are attached.

At the same time, food enterprises should also provide quality management standards, manufacturing operation standards, hygiene management standards, customer complaint offices, etc.

Technical documents such as management measures and finished product recycling system.

Second, the GMP evaluation methods and requirements of health food

In order to standardize the production of health food, improve the self-management level of health food enterprises, strengthen the health supervision and management of health food industry, and ensure the health of consumers, according to the Food Hygiene Law of People's Republic of China (PRC), the Measures for the Administration of Health Food, the General Hygiene Standard for Food Enterprises (GB- 1488 1) and the Good Manufacturing Practice for Health Food.

The review of health food production enterprises' implementation of good manufacturing practices for health food (hereinafter referred to as GMP) is divided into two aspects: data review and on-site review, which is still organized and implemented by the provincial health administrative department.

The specific procedure is:

(1) filing an application

Health food production enterprises that meet or basically meet GMP requirements may apply to the health administrative departments of all provinces (autonomous regions and municipalities directly under the Central Government) for examination. When applying, the following materials shall be submitted:

1. Application Report

2 health food production management and self-examination;

3. The management structure of the enterprise.

4. Copy of business license and health food approval certificate (not required for new factory);

5. Formulas, production processes and quality standards of main products of each dosage form, as well as process flow charts;

6. Introduce full-time technical personnel of enterprises;

7. Catalogue of products and production equipment produced by the enterprise;

8. The general plan of the enterprise and the plan layout of each production workshop (including people flow, logistics map, clean area division map, clean air flow chart, etc.). );

9. Introduction of personnel, facilities and equipment in the inspection room;

10. Quality assurance system (including enterprise production management and quality management document catalogue);

1 1. Report on technical parameters of clean area (cleanliness, pressure difference, temperature and humidity, etc. );

12. Other related resources.

(2) Data review

1. The provincial health administrative department shall organize a data review of the application documents submitted by the enterprise within 15 working days. If it is considered that the applicant enterprise has met or basically met GMP requirements through data review, it shall notify the applicant enterprise in writing and arrange on-site inspection.

Review. If it is considered that the applicant enterprise does not meet the requirements of on-site review through data review, it shall also notify the applicant enterprise in writing, and

Explain why.

(3) on-site review

On-site inspectors should be health supervisors who have received GMP evaluation training. The examiner shall conduct on-site inspection of the enterprise under review according to the Review Form of Good Manufacturing Practices for Health Food, record the facts and situations found in the on-site inspection, and ask the accompanying personnel to confirm.

(4) issue a GMP review result report.

Reviewers should summarize the results of on-site review, and make a review conclusion on the GMP implementation of the reviewed enterprise according to the Decision on Review Results within 5 working days after the end of on-site review. And report to the provincial health administrative department.

According to the influence of specific terms in GMP on product hygiene and safety, the review method divides the review items into key items.

Key projects and general projects. Key projects refer to projects that have a significant impact on the safety and hygiene of health food, and key projects refer to health care.

Food safety and hygiene have a greater impact on the project, other projects in general. Specific key projects, key projects and general projects are in

In the "health food good manufacturing practices review form" marked. GMP review results should be reviewed according to the evaluation result judgment table.

Fruit evaluation.

Health food production enterprises that basically meet the review results shall be ordered to make rectification within a time limit, and those that pass the rectification within 6 months shall be issued with health licenses; If the rectification is not carried out or the rectification is unqualified, the health permit shall not be issued.

For health food production enterprises that fail to pass the inspection, their hygiene licenses shall be cancelled.

Strengthen the management of entrusted production of health food. Health food production enterprises that fail to meet GMP after examination may entrust enterprises that meet GMP to produce. The entrusted enterprise must hold a valid health food production license, and the packaging label and instructions of the entrusted health food must indicate "xxxx production" and indicate the address of the entrusted production enterprise.

Three. Contents of food market access

It is an international practice to strengthen the supervision of food quality and children's safety. The United States, Japan, Canada and other developed countries have their own food quality and child safety supervision systems, and implement strict supervision systems for food, medicines and other products related to safety and health. Strict market access for food and food production enterprises, and the establishment and improvement of the market quasi-person system for food quality, hygiene and safety are the most effective ways to ensure the interests of the people. Since August 2002, the state has implemented a system of condition examination, compulsory inspection and market access for five types of food to ensure product quality. In 2003, there were 10 categories of foods allowed to enter the food market, namely meat products, dairy products, tea, beverages, condiments, convenience foods, canned foods, puffed foods, frozen foods and quick-frozen rice noodles. It is planned to complete the implementation of the food market access system in 3-5 years, and strengthen food quality and safety supervision from the source. In 2004-2005, there were 13 kinds of food that were allowed to enter the market. ...

1. Food market access content

The main contents of the food quality and safety market access system are:

First, enterprises engaged in food production and processing must have the corresponding basic conditions such as production equipment, testing means, measuring instruments and internal quality management system, and can only engage in food production and processing after obtaining the food production license;

Second, food must be inspected before leaving the factory.

Third, the food factory must be affixed with the food market access mark, namely QS (quality

Safety) quality and safety signs. Foods that do not meet the above conditions cannot enter the market for sale.

2. Food market access signs

Products that implement the food quality and safety market access system must be marked with the food production license number and stamped with the food market access mark on the food packaging of the smallest sales unit when leaving the factory. The serial number of food production license consists of QS and 12 Arabic numerals. QS is the abbreviation of quality and safety. The first four digits of the serial number are the accepting authority, the middle four digits are the product category number, and the last four digits are the serial number of the certified enterprise. Consumers can compare the administrative region where the enterprise is located indicated by the production license number with the address indicated by the enterprise, and judge whether there is any act of forging or fraudulently using the food production license and the food market access mark, or they can inquire the local quality and technical supervision department according to the administrative region where the enterprise is located indicated by the license number.

3.3' s directory. QS certification system document

Content: (1) quality policy and quality objectives; (2) Letter of appointment of quality director; (3) institutional setup; (4) expensive position; 5] Resource provision and management (I. Competency requirements of quality-related personnel; B, personnel training management system; C, equipment and facilities management regulations; D, testing equipment, measuring instruments management system; E, equipment operation and maintenance procedures; F, inspection side instrument operation procedures); [6] Product design (I. Process flow chart; B, process regulations); Once the supply of raw materials (a, procurement management system; B, average quality verification procedures; C, raw materials and finished products warehouse management system); Being production process quality control (a, production process quality control system; B, key process management system); (9) product quality inspection (1) inspection management system; B, product quality inspection procedures); ⑽ Management of nonconforming products (A, nonconforming product management measures, B, nonconforming product management system); ⑾ Technical document management system; ⑿ Health management system; [13] quality records.